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Prostate CancerPhase 3NCT01546623

A Phase 3 Comparative Study of TAP-144-SR(6M) in Prostate Cancer Patients Previously Treated With Hormonal Therapy

A Phase 3 study testing TAP-144-SR(6M) and TAP-144-SR(3M) in people with Prostate Cancer, run by Takeda at 16 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) against TAP-144-SR(3M) in prostate cancer patients previously treated with hormonal therapy. Read more about this study

Who is it for?
Ages 20 to 85 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
TAP-144-SR(6M) and TAP-144-SR(3M)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
16 sitesJapan
Study dates
Mar 2012to Apr 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant has histopathologically confirmed prostate cancer in Japanese.
  • The participant has prostate cancer in the clinical stages of T1b-T4, N-any and M-any by TNM classification on clinical diagnosis at the time of diagnosis.
  • The participant has ECOG performance status of grades 0, 1, or 2 at screening.
  • The participant with PSA level which has not increased 25 % or greater and 2 ng/mL or more from the nadir at the measurement points 4 weeks or longer apart within the screening period of 12 weeks.
  • Patients who receive the marketed product for 3 months (LEUPLIN SR FOR INJECTION KIT 11.25) at screening
  • Patients who have received the marketed products, TAP-144-SR (1M) and TAP-144-SR (3M), for 24-96 weeks in total at the scheduled starting date of the study drug, but not including administration period treated as neoadjuvant therapy for prostatectomy and/or radiation therapy
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  • Patients who have continued the nonsteroidal antiandrogen for longer than 12 weeks at the scheduled starting date of the study drug, if a nonsteroidal antiandrogen is concomitantly administered
  • The participant with a serum testosterone level at screening < 100ng/dL
  • The participant meets the following criteria of renal, bone-marrow and hepatic functions on the laboratory test results at screening:
  • （1） Renal function: serum creatinine level< 1.5 times the upper limit of normal (ULN) （2） Bone-marrow function: white blood count ≥ 3,500/ mm3, platelet count ≥ 100,000/L, hemoglobin ≥ 10.0g/dL （3） Hepatic function: AST(GOT), ALT(GPT), ALP and total bilirubin ≤ 2.5 times the ULN 10. The participant's life expectancy is at least 24 months at informed consent.

Who cannot join

  • The participant has active multiple primary cancers, (synchronous multiple primary cancer or metachronous multiple primary cancer with the disease-free survival ≤ 5 years)
  • The participant has received surgical castration.
  • The participant has ever received LHRH agonists other than commercially available 1-month or 3-month depot of leuprolide acetate.
  • The participant has ever received LHRH antagonists.
  • Patients who have previously received estrogen preparations or corticosteroids for prostate cancer
  • Patients who have previously received chemotherapy for prostate cancer
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  • Patients who are receiving or received the marketed product for 3 months (LEUPLIN SR FOR INJECTION KIT 11.25) or the marketed products for 1 month (LEUPLIN FOR INJECTION 3.75 and KIT 3.75) as an adjuvant therapy after prostatectomy and/or radiotherapy
  • Patients who are receiving or received the marketed product for 3 months (LEUPLIN SR FOR INJECTION KIT 11.25) for intermittent androgen deprivation therapy
  • Patients who received the following drugs within 24 weeks (168 days) after starting the study drug: Steroidal antiandrogens, type II 5α-reductase inhibitors
  • The participant received any of the following within 16 weeks (112 days) prior to study enrollment:
  • （1） Radiotherapy. As for I-125 brachytherapy, within 35 weeks (245 days) prior to study enrollment.
  • （2） Prostatectomy （3） Experimental therapy including high-intensity focused ultrasound therapy (HIFU), immunotherapy, and gene therapy 11. Patients who received the following drugs within 4 weeks (28 days) before starting the study drug: Testosterones, ketoconazole（except for external preparations）, spironolactone, corticosteroids (excluding their inhalants and external preparations), and Chinese medicines and dietary supplements containing saw palmetto 12. Patients whose QTcF interval exceeded 460 msec on the 12-lead electrocardiogram at screening 13. The participant has a history of hypersensitivity to synthetic LHRH, LHRH derivative or any component of the study drug.
  • 14. The participant has central nervous system metastasis which requires treatment or which is symptomatic.
  • 15. The participant already has a history or has a complication or may have renal disorder caused by spinal cord compression or ureteric obstruction.
  • 16. The participant has a history of serious drug allergic reaction/hypersensitivity 17. The participant has a history of, or has been diagnosed with thromboembolism including myocardial infarction, cerebral infarction, venous thrombosis, and pulmonary embolism, or cardiac failure

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Japan16 sites

  • Study site

    Ageo-shi, Saitama

  • Study site

    Chiba, Chiba

  • Study site

    Fukuoka, Fukuoka

  • Study site

    Itabashi-ku, Tokyo

  • Study site

    Kanazawa, Ishikawa-ken

  • Study site

    Kita-adachi-gun, Saitama

  • Study site

    Maebashi, Gunma

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Nigata-shi, Niigata

  • Study site

    Osaka, Osaka

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sendai, Miyagi

  • Study site

    Shinjuku-ku, Tokyo

  • Study site

    Shizuoka, Shizuoka

  • Study site

    Suita-shi, Osaka

  • Study site

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Phase 3, Multi-center, Randomized, Open-label, Parallel-group, Comparative Study of TAP-144-SR (3M) to Evaluate Hormone Dynamics, Pharmacokinetics, Safety and Efficacy of TAP-144-SR (6M) 22.5 mg Subcutaneous Injection for 48 Weeks in Prostate Cancer Patients Previously Treated With Hormonal Therapy

The purpose of this study is to evaluate hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) against TAP-144-SR(3M) in prostate cancer patients previously treated with hormonal therapy.

Conditions
Prostate Cancer
Being tested
TAP-144-SR(6M), TAP-144-SR(3M)
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAP-144-SR(6M)Drug

  • TAP-144-SR(3M)Drug

Study groups in NCT01546623
Study groupRoleWhat they receive
TAP-144-SR(6M)ExperimentalTAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
Receives: Drug: TAP-144-SR(6M)
TAP-144-SR(3M)Active comparatorTAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
Receives: Drug: TAP-144-SR(3M)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Rate of Suppression of Serum Testosterone to Castrate Level

    Comparison of the proportion of patients maintained at castration level (≤100 ng/dL)

    Measured: From the start of study drug administration through Week 48

Secondary outcomes (10)

  1. Time Course of Changes in Serum Testosterone

    Measured: From baseline to Week 48

  2. Time Course of Changes in Serum Luteinizing Hormone (LH)

    Measured: From baseline to Week 48

  3. Time Course of Changes in Serum Follicle-stimulating Hormone (FSH)

    Measured: From baseline to Week 48

  4. Time Course of Change Rate in Serum PSA (FAS)

    Evaluation according to the "Criteria for therapeutic effect" from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by prostate-specific antigen [PSA])

    Measured: From baseline to Week 48

  5. The Maximum Rate of Change in PSA Suppression (FAS)

    Evaluation according to the "Criteria for therapeutic effect" from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA)

    Measured: From baseline to Week 48

  6. Percentage of Participants With Progression by PSA (FAS)

    Evaluation according to the "Criteria for therapeutic effect" from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA)

    Measured: From baseline to Week 48

  7. Soft Tissue Response

    Assessment in accordance with the "criteria for therapeutic effect" from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition. Soft tissue response was evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: At week 48

  8. Bone Lesion Response

    Partially revised assessment based on the "criteria for therapeutic effect" from the General Rule for Clinical and Pathological Studies on Prostate Canter, 4th edition. Response is measured using bone scintigraphy. Increase in new (2 or more) bone lesion is considered as progression

    Measured: At Week 48

  9. Serum Unchanged TAP-144 Level

    Measured: From baseline to Week 48

  10. 12-lead ECG

    Measured: At 1 hour, week 24, and week 48 after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01546623
Sponsor's protocol ID
TAP-144-SR(6M)IP/CPH-002
Other IDs
U1111-1128-6861, JapicCTI-121763
Status last verified
Jun 2015
First submitted
28 Feb 2012
Last updated
21 Jul 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAP-144-SR(6M) and TAP-144-SR(3M) in people with Prostate Cancer, run by Takeda at 16 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Rate of Suppression of Serum Testosterone to Castrate Level (time frame: From the start of study drug administration through Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01546623.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015.

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